Custom EHR Regulatory Landscape: Understanding Development Requirements for EHR Development
As healthcare professionals, we both know the growing dependency of healthcare practices on electronic health records, and for good reasons. The EHR systems have not only facilitated quality patient care activities but also made it simple for administrators to manage data.
However, a generic EHR system hardly meets the unique needs of specialty healthcare practices. This has given rise to customized EHR software development, due to which healthcare practices were able to meet their specific workflows and functionalities.
Furthermore, given the sensitive nature of data that these EHR software deals with, patient data privacy and safeguarding of that data are extremely necessary. And since the healthcare industry is prone to cyber attacks, the government has laid down a legal framework to ensure patient privacy, data security, and system interoperability.
On that note, let’s navigate the legal, regulatory landscape for custom EHR software development. Let this blog be your guide to ensuring compliance with regulatory requirements.
Understanding Key Regulatory Frameworks of Custom EHR
Some of the key regulatory frameworks that you need to understand and adhere to are given below:
1. HIPAA (Health Insurance Portability and Accountability Act): HIPAA compliance in EHR software development is a major milestone that you need to achieve. Being a federal law, it not only regulates the legal landscape for the protection of health data but also its ethical use. That is why it is necessary for healthcare organizations to adhere to HIPAA to ensure patient privacy. Furthermore, failing to comply with HIPAA can lead to hefty fines and even reputation damage.
2. HITECH Act (Health Information Technology for Economic and Clinical Health Act): HITECH compliance in EHR development is similar to HIPAA, but this one majorly focuses on data security measures and meaningful use of the EHR system. However, the major aim of this act is to promote the use of healthcare IT systems and to achieve the desired healthcare outcomes.
3. Meaningful Use Criteria: The patient health information that your EHR system will collect can be used in many different ways. To ensure that it is only used for care delivery, the meaningful use criteria establish specific functionalities and data exchange requirements that your custom EHR needs to meet to meet the quality of incentive programs started by the government.
4. FDA (Food and Drug Administration): For remote monitoring of patient health vitals, you will have to rely on certain devices. To ensure that those devices are safe to use and FDA approval is needed.
Compliance Checklist for EHR Developers
Free DownloadTo help in comparing the major healthcare regulatory frameworks for custom EHR system, here’s a quick sneak peek into the healthcare regulatory frameworks and what you need to know about them:
| Regulatory Framework | Primary Focus | Key Requirements | Implementation Considerations |
| HIPAA (Health Insurance Portability and Accountability Act) | Protects patient health information (PHI) | – Privacy Rule- Security Rule- Breach Notification Rule | – Must implement physical, technical, and administrative safeguards- Requires role-based access and audit logging- Applies to all covered entities and business associates |
| HITECH Act (Health Information Technology for Economic and Clinical Health) | Promotes EHR adoption and meaningful use | – Meaningful Use stages (now Promoting Interoperability)- Increased penalties for HIPAA non-compliance | – Requires certified EHR technology (CEHRT)- Encourages patient engagement and data sharing |
| ONC Health IT Certification | Ensures EHR systems meet standardized functional, security, and interoperability criteria | – Support for USCDI- FHIR API capability- Clinical quality measures- Data export functionality | – Mandatory for CEHRT used in CMS incentive programs- Involves rigorous testing against ONC’s criteria |
| GDPR (General Data Protection Regulation – EU) | Data protection and privacy for EU citizens | – Consent management- Right to access and delete data- Data breach notification | – Applies to US-based providers handling EU patient data- Requires clear consent workflows and cross-border data safeguards |
| TEFCA (Trusted Exchange Framework and Common Agreement) | Nationwide interoperability in the U.S. | – Standardized exchange via QHINs- Common policies for data sharing- Patient access and transparency | – Participation is voluntary, but becoming more influential- Aligns with FHIR and existing ONC rules |
| 21st Century Cures Act (Information Blocking Rule) | Prohibits data blocking and promotes patient access | – APIs for data sharing- Open notes requirement- Defines allowable exceptions to sharing | – Requires a cultural and technical shift for providers- Non-compliance can lead to financial penalties |
Interoperability Standards
Now that we’ve covered most of the legal requirements for EHR software development, let’s have a look at the interoperability standards that you need to adhere to for the seamless flow of data from one healthcare system to another.
1. Compliance with FHIR (Fast Healthcare Interoperability Resources)
FHIR standards are nothing but a set of standards that allow disparate healthcare systems to seamlessly exchange data between healthcare information systems. HL7 FHIR acts as a common ground for the healthcare system to communicate with each other in an understandable manner and seamlessly share information.
By complying with HL7 and FHIR, you can securely and seamlessly exchange patient data with various healthcare providers and care team members to deliver timely care.
However, the compliance frameworks might change depending on the region you’re practicing in. Here, it becomes necessary to identify those national and international interoperability guidelines to ensure that the data is shared in a safe environment and does not land you or your practice in legal trouble. For instance, if you’re practicing in European Union countries, then GDPR compliance in EHR development is necessary, along with other necessary interoperability.
Patient Consent & Authorization
For virtual care delivery, you first need to attain patient consent from the patient as a green signal from the patient to allow you to use their data and deliver care. And obtaining patient consent is easier said than done. While there are several ways that you can use to get their patient consent, digital patient consent or physical consent are some of the best ways to get it.
Furthermore, for your virtual care delivery program, you need to implement a functional mechanism for obtaining patient consent. Draft a clear patient consent form for data collection, storage, and sharing of patient health data within the custom EHR system for delivering care.
For this, you also need to comply with the legal requirements for patient data sharing. One of the best examples of this can be the HIPAA authorization forms, which provide you with all the necessary guidelines that you need to adhere to for sharing patient data.
Last but not least, make your custom EHR software a one-stop solution for healthcare delivery, where you can incorporate features within your system to effectively manage patient consent and authorization processes. Clearly outline the process of getting consent and align your software in that way to ensure you get patient consent before starting to collect their data and deliver care.
Building a Secure & Compliant EHR System
The sensitive nature of patient data that your EHR system deals with and the healthcare industry being prone to cyberattacks make it necessary for you to build a secure and compliant EHR system. Here are some of the compliance strategies for EMR software development that you can use for building a secure EHR system:
1. Data Security Best Practices: Data encryption best practices in healthcare IT are used widely for protecting sensitive patient data. Furthermore, role-based access controls for restricting unauthorized access and audit trails for tracking system activity are some of the best practices that you can use to ensure that your data is secure.
2. Implementing User Authentication and Authorization Protocols: Implement robust user authentication mechanisms like passwords or multi-factor authentication and authorization protocols to define the roles of users who can access patient data and who require permission from the admin to access that data from the EHR system.
3. Ensuring Data Integrity and System Validation: Maintaining data integrity is crucial for care delivery and reimbursement. By implementing a data validation process, you can not only improve the accuracy of the data that is being shared but also ensure the completeness of patient data within the EHR.
4. Maintaining Compliance with Ongoing Regulatory Updates: The healthcare landscape is changing with technology, and that is changing the regulatory landscape as well. That is why you need to stay updated with the new regulations and implement the necessary changes every now and then within your custom EHR system to ensure your system is always compliant and in adherence with the regulatory landscape.
Testing EHR Systems for Compliance
In 2023, the US Department of Health and Human Services (HHS) Office for Civil Rights reported more than 725 breaches. These breaches exposed more than 133 million health records. These breaches not only impact your reputation amongst patients but also can lead to hefty penalties. That is why it is important to test your EHR systems for compliance. Let’s see this comprehensive testing process step by step for your custom EHR system:
1. Risk Assessment & Security Testing: Conduct a thorough risk assessment to identify vulnerabilities that would put patient data at risk. One of the best ways to identify these vulnerabilities is by performing a penetration test so that you can proactively identify the gaps. Along with that, you can also ensure that the robust security measures implemented by you are functioning properly, like encryption, access controls, and audit trails.
2. Define Scope & Objectives: When testing for compliance, you need to very clearly and specifically define the objectives for testing. These objectives might include functionality, errors, assessing performance, and compliance with regulations. Moreover, the testing scope can include the scope to include infrastructure readiness, application configuration, workflow accuracy, and staff training readiness.
3. Validate Compliance with Privacy & Security Regulations: There are several regulations for privacy and security. Identify those compliances, such as HIPAA, HITECH, GDPR, or local regulations, and ensure that your EHR system is compliant with them. Review the encryption methods used with secure transmission protocols and data storage practices. And while you’re at it, also test for breach notification if they are in place.
Given the increasing number of cyberattacks on healthcare systems, here is a quick roadmap for you to prepare your system for regulatory audits and inspections:
- Document policies, procedures, and training.
- Conduct internal audits and continuous monitoring.
- Prepare audit-ready documentation and evidence.
- Engage key stakeholders and testing teams in this process.
Partnering with the Right Experts
To adhere to the legal requirements for EHR software development, you need to partner with experienced custom EHR developers. Since they already have experience in developing robust custom EHR systems, their deep understanding of the healthcare regulations and data security best practices speeds up the process for you.
Furthermore, you can collaborate with legal and compliance professionals to ensure that your custom EHR software system is in compliance with all the relevant regulations. Though it is hardly a common practice, utilizing it can help you build a secure and compliant EHR system, saving a lot of time and potentially causing trouble for your custom EHR development.
Last but not least, leverage industry-specific resources and guidelines provided by healthcare organizations and regulatory bodies. Your custom EHR system is not only safe and secure but also interoperable and an integral part of the healthcare landscape.
Also, one of the best practices to align your EHR system with regulatory compliance is to begin the compliance process during the development phase. Here’s a quick breakdown that you can ask your EHR software development company to align their compliance practices with:
| Phase | Key Activities | Compliance Focus | Milestones |
| 1. Planning & Requirements | – Market analysis- Define user & system requirements- Identify regulatory needs | – Understand HIPAA, HITECH- Consider ONC Health IT Certification criteria- TEFCA awareness | – Regulatory requirements documented- Security & privacy frameworks selected |
| 2. Design & Architecture | – Design system architecture- Plan for interoperability (FHIR, HL7, APIs)- UX/UI planning | – Plan for data encryption, audit logging- Incorporate access control standards | – Security design review complete- Interoperability standards embedded |
| 3. Development & Integration | – Build core modules (e.g., ePrescribing, charting)- Integrate APIs, health info exchanges | – Apply HIPAA technical safeguards- Ensure data integrity & audit logging | – Unit & integration testing done- Internal security checks passed |
| 4. Testing & Validation | – Perform functional, security, and compliance testing- End-user feedback loop | – ONC Certification test cases- Validate against USCDI data elements- Privacy impact assessment | – Certification-ready build- Privacy and security testing passed |
| 5. Certification & Launch Prep | – Submit for ONC Health IT Certification- Prepare user documentation & training | – ONC 2015 Edition Cures Update- Accessibility & safety standards | – ONC certification obtained- Training materials finalized |
| 6. Post-Market Surveillance & Updates | – Monitor system performance- Respond to user-reported issues- Release periodic updates | – Maintain HIPAA compliance- Adhere to CMS & ONC update guidelines | – Audit logs are reviewed regularly- Annual compliance assessments complete |
Conclusion
In the dynamic landscape of healthcare, EHR software development offers tailored solutions to meet diverse institutional needs. However, amidst this flexibility lies a labyrinth of legal and regulatory challenges. Navigating these complexities demands a comprehensive understanding of frameworks like HIPAA, HITECH, and FDA regulations, alongside ensuring interoperability, patient consent, data security, and compliance updates.
Collaboration with experts and leveraging industry resources are pivotal in crafting EHR systems that not only meet regulatory standards but also uphold patient privacy and healthcare quality. And also, by complying with the necessary regulations, you can not only avoid any hefty penalties but also maintain a firm reputation in the market for enhanced security practices.
On that note, let’s start your healthcare practice’s transformation journey today. Click here to kick-start your custom EHR software development venture.
Frequently Asked Questions
Custom EHR developers must comply with several key legal regulations, including HIPAA (Health Insurance Portability and Accountability Act), HITECH (Health Information Technology for Economic and Clinical Health Act), and state-specific regulations. These laws aim to protect patient privacy, ensure data security, and maintain the integrity of healthcare information.
To ensure HIPAA compliance in custom EHR systems, implement strong encryption for data at rest and in transit. Utilize robust access controls, including multi-factor authentication and role-based access, to restrict access to authorized personnel only. Regularly audit access logs and conduct thorough security risk assessments to identify and mitigate potential vulnerabilities.
Here are 5 key steps for GDPR compliance in EHR systems:
- Data Minimization: Collect and store only necessary patient data.
- Consent: Obtain explicit and informed patient consent for data processing.
- Data Security: Implement robust security measures (encryption, access controls) to protect data from breaches.
- Data Subject Rights: Ensure patients can exercise their rights (access, rectification, erasure) regarding their data.
- Data Breach Notification: Establish procedures for promptly notifying authorities and affected individuals of any data breaches.
Interoperability in custom EHR development allows seamless data exchange between different healthcare systems. This improves patient care, reduces errors, and streamlines workflows. Developers should adhere to standards like HL7 FHIR and DICOM to ensure compatibility and data integrity.
best practices for preventing cybersecurity threats and data breaches in EHR systems:
- Strong passwords: Enforce complex and unique passwords for all users.
- Access control: Implement robust role-based access control (RBAC) to limit user privileges.
- Data encryption: Encrypt data both at rest and in transit.
- Regular updates: Keep EHR software and operating systems up-to-date with the latest security patches.
- Employee training: Educate staff on cybersecurity best practices, including phishing awareness.
- Regular audits: Conduct regular security audits and penetration testing to identify vulnerabilities.
By following these practices, healthcare organizations can significantly reduce the risk of cyberattacks and protect sensitive patient data.
Non-compliance with healthcare regulations can result in severe financial penalties, legal repercussions, reputational damage, and even suspension of operations.
To ensure your custom EHR solution meets the latest security standards, implement robust encryption, enforce strict access controls, conduct regular security audits, and stay up-to-date with relevant regulations and best practices.
To address questions about specific regulatory requirements, I recommend:
- Consult the relevant regulatory body: Directly contact the agency responsible for overseeing the specific area.
- Seek expert advice: Engage with legal or compliance professionals specializing in the relevant regulations.
- Review official guidance documents: Thoroughly examine official guidance, FAQs, and interpretations issued by the regulatory body.
- Attend industry events and training: Participate in workshops and seminars to gain insights and network with others facing similar challenges.
- Stay updated on regulatory changes: Continuously monitor for updates and amendments to relevant regulations.
